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Completed

NCT Number: NCT00739674

SAALT: Subtracting Salt and Adding Losartan Trial (0954A-335)

To evaluate the effectiveness of diet management with a losartan based titration regimen versus losartan based titration regimen alone on blood pressure reduction in hypertensive patients.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Non Diabetic, Newly Diagnosed And Untreated For Mild To Moderate Hypertension (blood pressure > 161; < 221; 140/90 mm Hg But < 180/110 mm Hg)
  • Non diabetic, newly diagnosed and untreated for severe hypertension (blood pressure > 180/110 mm Hg but < 200/120 mm Hg); Patients who are asymptomatic with no evidence of significant end organ damage including direct pressure effects can be included. Patients in an urgency/emergency state are to be excluded
  • Or Diabetic, Newly Diagnosed With Hypertension And Untreated With Mild To Moderate Hypertension (blood pressure > 161;< 221; 130/80 mm Hg But < 160/100 mm Hg); Or Patient Receiving One Antihypertensive Agent (Monotherapy Only) Used To Treat Hypertension For At Least 4 Weeks And Whose Blood Pressure Is Not Controlled: blood pressure > 161;< 221; 140/90 mm Hg But < 160/100 mm Hg Or For Diabetic And/Or Coronary Artery Disease Patients: blood pressure > 161;< 221; 130/80 mm Hg But > 161;< 221; 150/90 mm Hg
  • The Antihypertensive Agent Will Need To Be Discontinued Prior To Starting Study Drug

Exclusion criteria

  • Known Secondary Hypertension Of Any Aetiology (E.G., Uncorrected Renal Artery Stenosis, Malignant Hypertension, Hypertensive Encephalopathy. Patient With Symptomatic Heart Failure (Classes 3 And 4). Patient With A Prior Myocardial Infarction Or Stroke Within The Last 6 Months
  • Patient Has Undergone Percutaneous Coronary Angioplasty, Has Had Coronary Artery Bypass Within The Last 6 Months Or Has Unstable Angina
  • Patient With Anuria Or Confirmed Clinically Significant Renal Or Hepatic Dysfunction (Taken From Current/Past Medical Records) And/Or Electrolyte Imbalance Laboratory Test Within The Last 3 Months Prior To Visit 1: Serum Creatinine > 130 Ìmol/L Or Creatinine Clearance < 45 Ml/Min, Ast > 3 Times Above The Normal Range, Alt > 3 Times Above The Normal Range, Serum Potassium < 3.5 Or > 5.5 Meq/L
  • Significant Liver Or Respiratory Disease, Cancer Or Other concomitant Disease That Is Likely To Affect Life Expectancy Of The Patient

Treatment and study plan

losartan potassium (+ hydrochlorothiazide [HCTZ] + calcium channel blocker [CCB])

Drug

Losartan 50 mg or 100 mg once daily for 40 weeks with sequential titration including HCTZ 12.5 mg or 25 mg and CCB only as needed to achieve target blood pressure, as follows:

Patients with mild-moderate hypertension, uncontrolled hypertension on monotherapy, or diabetes:

  • Losartan 50 mg
  • Losartan 100 mg
  • Losartan 100 mg/HCTZ 12.5 mg
  • Losartan 100 mg/HCTZ 25 mg
  • Losartan 100 mg/HCTZ 25 mg + CCB

Patients with severe hypertension:

  • Losartan 50 mg/HCTZ 12.5 mg
  • Losartan 100 mg/HCTZ 12.5 mg
  • Losartan 100 mg/HCTZ 25 mg
  • Losartan 100 mg/HCTZ 25 mg + CCB
  • Losartan 100 mg/HCTZ 25 mg + increasing CCB

Low salt diet

Behavioral

Low-salt intake diet (Dietary Approaches to Stop Hypertension [DASH]) including:

  • Healthy diet
  • Reduction in sodium intake to less than 2300 mmol/day
  • Low alcohol consumption (less than 2 standard drinks/day)

Primary outcomes

  1. Number of Patients Achieving Target Blood Pressure at Week 14 From Baseline

    Time frame: 14 Weeks

    Number of Patients Achieving Target Blood Pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics) from baseline after 14 weeks of treatment

  2. Change in Systolic Blood Pressure From Baseline to Week 14

    Time frame: 14 Weeks

  3. Change in Diastolic Blood Pressure From Baseline to Week 14

    Time frame: 14 Weeks

Secondary outcomes

  1. Number of Patients Achieving Target Blood Pressure at Week 6 From Baseline

    Time frame: 6 Weeks

    Number of Patients Achieving Target Blood Pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics) from baseline after 6 weeks of treatment

  2. Number of Patients Achieving Target Blood Pressure at Week 10 From Baseline

    Time frame: 10 Weeks

    Number of Patients Achieving Target Blood Pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics) from baseline after 10 weeks of treatment

  3. Number of Patients Achieving Target Blood Pressure at Week 40 From Baseline

    Time frame: 40 Weeks

    Number of Patients Achieving Target Blood Pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics) from baseline after 40 weeks of treatment

  4. Change in Systolic Blood Pressure From Baseline to Week 6

    Time frame: 6 Weeks

  5. Change in Diastolic Blood Pressure From Baseline to Week 6

    Time frame: 6 Weeks

  6. Change in Systolic Blood Pressure From Baseline to Week 10

    Time frame: 10 Weeks

  7. Change in Diastolic Blood Pressure From Baseline to Week 10

    Time frame: 10 Weeks

  8. Time to Achieve the Target Blood Pressure From Baseline

    Time frame: 14 Weeks

    Time to achieve the target blood pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics).

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

Randomized Open-label Trial to Evaluate the Effectiveness of Diet Management With a Losartan Titration Regimen Versus Losartan Titration Regimen Alone on Blood Pressure Reduction in Hypertensives.

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Aug 22, 2008
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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